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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Siemens Healthcare Diagnostics Vista Air Compressor Siemens Healthcare Diagnostics Dimension Vista® System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
Recall Number Z-1733-2014
Classification Class II
Code Info Product Siemens Material Number (SMN) Dimension Vista® 500 Domestic: 10284473 International: 10488224 Dimension Vista® 1500 Domestic: 10444801 International: 10444802
Product Distributed Qty 4
Reason For Recall Siemens Healthcare Diagnostics is recalling the Vista Air Compressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy,used on the Dimension Vista® 500 and Dimension Vista® 1500 systems because a small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.

Event Detail

Event Id 68076
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc.
City Newark
State DE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.